What 21 CFR Part 821 - Medical Device Tracking Requirements (FDA Tracking Orders for Class II and Class III Devices) requires
21 CFR Part 821 implements section 519(e) of the Federal Food, Drug, and Cosmetic Act and prescribes the FDA medical device tracking regime applicable to Class II or Class III devices where a failure of the device would be reasonably likely to have serious adverse health consequences, devices intended to be implanted in the human body for more than one year, or devices intended to be a life-sustaining or life-supporting device used outside a device user facility. Section 821.1(c) places the primary burden of ensuring the tracking system works on the manufacturer. Tracking is not automatic by class - under section 821.20(a) a device only becomes a tracked device when the FDA issues a tracking order to the manufacturer in a premarket notification, premarket approval response, or postmarket order. Section 821.25 requires a manufacturer of a tracked device to adopt a tracking system that allows it to provide FDA, within three working days of an FDA request prior to distribution, with the name, address, telephone number, and location of the distributor or multiple distributor holding the device, and within ten working days of an FDA request after distribution to a single-patient device, the unique device identifier (UDI), lot number, batch number, model number, or serial number, the date shipped by the manufacturer, the name, mailing address, telephone number, and social security number of the patient (subject to patient release under section 821.55(a)), the date the device was provided to the patient, the prescribing and following physician details, and where applicable the explant date and explanting physician, the patient death date, or the date the device was returned, retired, or permanently disposed of. Section 821.25(c) requires a written standard operating procedure including a quality assurance audit at not less than six-month intervals for the first three years of distribution and at least once a year thereafter. Section 821.30 places downstream obligations on distributors, final distributors, and multiple distributors to promptly forward identifiers, receipt dates, prescribing physician details, and patient information to the manufacturer; multiple distributors must respond to manufacturer requests within five working days and to FDA requests within ten working days. Section 821.50 makes records available to FDA upon presentation of credentials and FDA Form 482 and requires centralized U.S. recordkeeping. Section 821.55 lets a patient refuse release of identifying information and protects records from public disclosure under 21 CFR Part 20. Section 821.60 requires retention for the useful life of the tracked device. Section 821.2 permits petitions for exemption or variance under the procedures in 21 CFR 10.30.
Pillar: Medical & Healthcare · Authority: United States Food and Drug Administration, Center for Devices and Radiological Health, implementing section 519(e) of the Federal Food, Drug, and Cosmetic Act as codified at 21 USC 360i(e), with the regulatory text published in the Code of Federal Regulations Title 21 Part 821 and maintained on a current basis by the Office of the Federal Register · Version: 1.0.0 · Last updated:
Primary source: https://www.govinfo.gov/content/pkg/CFR-2024-title21-vol8/xml/CFR-2024-title21-vol8-part821.xml
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Primary Citations — 8 traced to source
- 21 CFR 821.1 - Scope - implements section 519(e) of the Federal Food, Drug, and Cosmetic Act for Class II or Class III devices where failure is reasonably likely to have serious adverse health consequences, where the device is intended to be implanted in the human body for more than one year, or where the device is intended to be a life-sustaining or life-supporting device used outside a device user facility; Section 821.1(c) places the primary burden of ensuring the tracking system works on the manufacturer
- 21 CFR 821.2 - Exemptions, variances, and alternative tracking methods - permits a manufacturer, importer, or distributor to petition for exemption or variance from one or more Part 821 requirements under the citizen-petition procedures of 21 CFR 10.30; exemptions are effective only on approval by the FDA Center for Devices and Radiological Health
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